Design controls

Our software is used by medical device organisations across the globe to manage the design control process. Configurations of our software have been approved as compliant with the FDA and MHRA requirements to plan, record, report and monitor all changes to design control documents, risk management and processes.

 
Complex circle

Software for design control management

Design control SOP

Define and manage the requirements and processes for Design and Development of new products. Plan and manage the process for auditing of the Design History File.

Design & development planning

Document Manager enables you to manage a formal approval process. Furthermore, changes can be controlled using audit trails, notifications and electronic signatures.

Design input

Define the process for collecting user requirements, reviewing and approving those requirements and use Issue Manager for a formal process to resolve incomplete, missing, ambiguous or conflicting requirements.

Design output

Define the process for converting the requirements into physical manifestation using risk analyses, traceability matrices, detailed design specifications.

Design verification and validation

Plan, protocols, test data, verification and validation reports are all managed in a single system.

Design review SOP

Plan, schedule and record outputs of design review inspections and audits.

Design transfer

Detail the processes for planning and execution of the transfer of the design to manufacturing.

Medical device companies using our software

pharma qms software
pharmaceutical quality control and assurance software and systems
pharmaceutical qms software
pharmaceutical quality management software systems
Pharma compliance management software
Biotech quality management software
pharmaceutical quality management software
York instruments medical devices quality management software solution
Medical device manufacturers ISO 13485 DYSIS

Medical device datasheet

Read how each of our software modules helps you to comply with ISO 13485:2016, the FDA and MHRA requirements.

Computer system validation

Read how Qualsys helps you throughout the system and process validation process.

Related information

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Validation
Global pharmaceutical businesses, NHS trusts and other life-science businesses have been able to validate our software as compliant with the requirements of regulations such as GAMP 5, ISO 9001, ICH GCP E6 and FDA 21CFR Part 11, and electronic signature legislation such as the EU Electronic Signatur...
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Articles about design control and ISO 13485

ISO 13485:2016 clauses and how our software helps you comply
Organisations who design, develop, produce, or install medical device products or services often make a strategic decision to certify to ISO 13485:2016. ISO 13485 harmonises medical device regulatory requirements and provides a best practice framework for a medical device quality management system....
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3 mistakes to avoid when planning your Trial Master File
The trial master file (TMF) needs to provide a complete story of how your trial was conducted and managed. As as quality and compliance manager, this can seem incredibly daunting as a mistake at the start of the process could result in the clinical trial being rejected.
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See how our software helps you manage the entire design control process. Request a 30 minute demonstration.

Our directors travel a lot. For them to have a secure and comprehensive set of documents that they can always refer to and share with our customers, I think is incredibly important.

Susanne Durie – Head of Quality, Nanopharm